NCT02979015

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects. Secondary Objectives: * To assess the pharmacokinetic profile of a single SC dose of alirocumab. * To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters. * To assess the immunogenicity of a single SC dose of alirocumab.

Detailed description

Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	alirocumab SAR236553 (REGN727)	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	placebo	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2016-11-29
• Primary completion: 2017-11-27
• Completion: 2017-11-27
• First posted: 2016-12-01
• Last updated: 2017-12-05

Locations

1 site across 1 country: China